Preconference Short Courses
Join us prior to the meeting on June 14
Short Courses are designed to enhance your knowledge in a broad or specific area for your day-to-day job function. Short Courses are an additional fee to the meeting registration cost.
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Half Day
#19: Core Labeling Short Course
9:00AM-12:30PMThis short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, how local labeling changes and regulatory requirements may have an impact on CCDS. In addition, it will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments.
#21: Real World Evidence: The Evolving Landscape of Regulators, Data and Integrated Use
9:00AM-12:30PMReal world evidence (RWE) has the potential to compliment and extend the safety and effectiveness knowledge of drugs gained from RCTs. This short course will discuss key study design principles to guide evaluation of RWE using studies focused on cardiovascular safety assessments.
#22: Data Visualization in the Life Sciences
9:00AM-12:30PMTraditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues.
#24: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
9:00AM-12:30PMThis short course will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.
#25: Regulatory Requirements for IND/NDA Procedures in China
9:00AM-12:30PMTraditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues.
#26: "Has it Happened Already?" Questions of Precedent from Which Regulatory Intelligence Can Save You
9:00AM-12:30PMThis intent of this short course is to provide a quick overview and practical insight into locating, analyzing, and applying precedent as an aid to making better strategic regulatory decisions.
#23: Protocol Co-Design with Patients and Advocates
1:30-5:00PMThis short course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates.
#28: Leadership: How to Organize and Lead People in a Work Group
1:30-5:00PMThe role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.
#33: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
1:30-5:00PMThe instructors will take you through the development of a cross-functional, quality strategy framework in an R&D QA organization, which when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle.
#34: Preparing for a US FDA Advisory Committee Meeting
1:30-5:00PMWhat are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting.
#35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
JUNE 12 | 8:30-11:30AMSignificant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor, and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation, and J-NDA preparation and review.